Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- incidence of hypotension
研究概览
简要总结
This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section
详细描述
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.
The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 48 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult parturients, American Society of Anesthesiologists (ASA) I-II,
- •singleton gestation>37 weeks
- •elective cesarean section
排除标准
- •Body Mass Index (BMI) >40 kg/m2
- •Body weight <50 kg
- •Body weight>100 kg
- •height<150 cm
- •height>180 cm
- •multiple gestation
- •fetal abnormality
- •fetal distress
- •active labor
- •cardiac disease
- •pregnancy-induced hypertension
- •thrombocytopenia
- •coagulation abnormalities
- •use of antihypertensive medication during pregnancy
- •communication or language barriers
- •lack of informed consent
- •contraindication for regional anesthesia
研究组 & 干预措施
norepinephrine infusion and colloid preloading (NOR-COL)
in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)
干预措施: norepinephrine infusion and colloid preloading (NOR-COL) (Procedure)
norepinephrine infusion and crystalloid co-loading (NOR-CRYS)
in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)
干预措施: norepinephrine infusion and crystalloid co-loading (NOR-CRYST) (Procedure)
结局指标
主要结局
incidence of hypotension
时间窗: intraoperative
any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded
次要结局
- neonatal blood gases(1 min post delivery)
- need for vasoconstrictor(intraoperative)
- type of vasoconstrictor administered(intraoperative)
- total dose of vasoconstrictor administered(intraoperative)
- incidence of bradycardia(intraoperative)
- need for atropine(intraoperative)
- modification or cessation of the infusion(intraoperative)
- incidence of nausea/vomiting(intraoperative)
- Neonatal Apgar score at 1 min(1 min post delivery)
- Neonatal Apgar score at 5 min(5 min post delivery)
- glucose in neonatal blood(1 min post delivery)
- incidence of hypertension(intraoperative)
研究者
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital
